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IRCT20200601047625N1 IRCT 2023-06-19 Esfahan University of Medical Sciences Effectiveness of Lumbar support on Pain in Postpartum Pelvic Pain Effectiveness of Lumbar support on Pain, Disability, and Motor Control in Women with Postpartum Pelvic Girdle Pain: a Randomized Controlled Trial 2023-06-22 anticipated 84 Complete https://irct.ir/trial/70670 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Intervention allocation will be carried out by block randomization method such that an equal number will be assigned to each study group. Once participants are confirmed to be eligible, they will be randomly assigned to one of three study groups with equal allocation at a 1:1:1 ratio (control or pelvic belt or lumbar support). Based on block randomization (each block, n=6), the examiner will perform randomization with a Random Allocation Software. Examiner will choose blocks randomly and will allocate participants according to the serial assignment. N/A Pregnancy-related posterior pelvic girdle pain (PPGP). Intervention 1: Intervention group: Pelvic belt. The participants will receive a pelvic belt. It is made from breathable textile material to provide comfort for the participant. The pelvic belt will be an adjustable strap (width 10-15cm) fastened just under ASIS. Belt will be available in different sizes and fitted individually by a trained examiner to provide the best possible personalized orthosis. The fitting method and the minimum expected using time (4 hours a day) of orthosis will be explained and demonstrated to all users. Intervention 2: Intervention group: lumbar/pelvic support. The lumbar/pelvic support consists of a pelvic belt attached to the lumbar corset. The support has a 25-cm width anteriorly and extends from the xiphoid process to the pelvis. It has a 35-cm width posteriorly and extends down from the lower angle of the scapula to gluteal prominences. It has 3 panel with 10 cm width: one transverse panel placed inferior to ASIS, and two other crossed panels positioned on abdominal muscles. Support will be available in different sizes and fitted individually by a trained examiner to provide the best possible personalized orthosis. The fitting method and the minimum expected using time (4 hours a day) of orthosis will be explained and demonstrated to all users. Intervention 3: Control group: Education leaflet. control group will receive only a patient education leaflet containing advice on strengthening exercises, comfortable positions (standing, walking, sleeping, and lifting), and other practical information. Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shared with other researchers or systematic reviewers. When: Data will be shared once findings are come up or summary date is published. To whom: Data will be shared personally and for academic purposes only. Conditions: Data will be shared for teaching or research. Fahimeh Sadat Jafarian (correspondence) will review the requests. Where to obtain: People can sent their request to the correspondence and obtain the data. How to obtain: Request should be sent through an email (fahimejafarian@yahoo.com). Comments:
public Fahimeh Sadat Jafarian
Isfahan University of Medical Sciences, Rehabilitation School, Orthotics and Prosthetics Department
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5000 fahimejafarian@yahoo.com Esfahan University of Medical Sciences scientific Fahimeh Sadat Jafarian
Isfahan University of Medical Sciences, Rehabilitation School, Orthotics and Prosthetics Department
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5000 fahimejafarian@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Primipara women who experienced natural delivery (one month before) Self-reported pregnancy-related posterior pelvic girdle pain (PPGP) A pain score of at least 40 out of100 mm on the visual analog scale (VAS) A score of higher than 2 out of 5 on a 6-point Likert scale for perceived effort during the ASLR test Age between 18 and 45 years Confirm the unilateral sacroiliac joint pain 18 years 45 years Female The presence of lower back or pelvic pain before pregnancy History of any fracture in the pelvis and lower extremities History of spine, pelvis, and lower extremity surgery Neurological diseases Limb length discrepancy Congenital anomaly in the spine, pelvis, and lower extremities Using any other conservative treatment for pain relief during the study R10.2 Pelvic and perineal pain Treatment - Devices Treatment - Devices Other Intervention group: Pelvic belt. The participants will receive a pelvic belt. It is made from breathable textile material to provide comfort for the participant. The pelvic belt will be an adjustable strap (width 10-15cm) fastened just under ASIS. Belt will be available in different sizes and fitted individually by a trained examiner to provide the best possible personalized orthosis. The fitting method and the minimum expected using time (4 hours a day) of orthosis will be explained and demonstrated to all users. Intervention group: lumbar/pelvic support. The lumbar/pelvic support consists of a pelvic belt attached to the lumbar corset. The support has a 25-cm width anteriorly and extends from the xiphoid process to the pelvis. It has a 35-cm width posteriorly and extends down from the lower angle of the scapula to gluteal prominences. It has 3 panel with 10 cm width: one transverse panel placed inferior to ASIS, and two other crossed panels positioned on abdominal muscles. Support will be available in different sizes and fitted individually by a trained examiner to provide the best possible personalized orthosis. The fitting method and the minimum expected using time (4 hours a day) of orthosis will be explained and demonstrated to all users. Control group: Education leaflet. control group will receive only a patient education leaflet containing advice on strengthening exercises, comfortable positions (standing, walking, sleeping, and lifting), and other practical information. Pain severity. Timepoint: The pain score will be measured at four time points in intervention groups: (1) baseline, (2) immediately after the intervention, (3) four-week after the interventions began, and (4) one-week after discontinuing the interventions. In control group, the pain score will be measured at three time points: (1) first session, (2) four-week after the study began, and (3) five-week after the study began. Method of measurement: She will score her pain by visual analog scale (VAS) ranged from 0 to 10; zero means no pain, and 10 presents the worst imaginable pain. Effort score during active straight leg raising test. Timepoint: The effort score will be measured at four time points in intervention groups: (1) baseline, (2) immediately after the intervention, (3) four-week after the interventions began, and (4) one-week after discontinuing the interventions. In control group, the effort score will be measured at three time points: (1) first session, (2) four-week after the study began, and (3) five-week after the study began. Method of measurement: Subjects will score the difficulty to perform the test on a 6-point Likert scale (ranging from 0 to 5); zero presents no difficulty, and five means unable to do. Maximum isometric hip flexion force. Timepoint: The maximum isometric hip flexion force will be measured at four time points in intervention groups: (1) baseline, (2) immediately after the intervention, (3) four-week after the interventions began, and (4) one-week after discontinuing the interventions. In control group, the maximum isometric hip flexion force will be measured at three time points: (1) first session, (2) four-week after the study began, and (3) five-week after the study began. Method of measurement: Digital force gauge (Digital Force Gauge, SF-500, Akurasi, 0.001kg) will be attached to the metal bar and adjusted in which is located just above the ankle. The subject will be asked to raise her involved leg and compress the force gauge probe while the leg is still lying on the table. Maximum isometric hip external rotation force. Timepoint: The maximum isometric hip external rotation force will be measured at four time points in intervention groups: (1) baseline, (2) immediately after the intervention, (3) four-week after the interventions began, and (4) one-week after discontinuing the interventions. In control group, the maximum isometric hip external rotation force will be measured at three time points: (1) first session, (2) four-week after the study began, and (3) five-week after the study began. Method of measurement: Subjects will perform isometric muscle strength testing for hip external rotation using digital force gauge and a stabilization strap. The subject will be asked to pull her leg inward with maximal effort. Maximum isometric trunk rotation force. Timepoint: The maximum isometric trunk rotation force will be measured at four time points in intervention groups: (1) baseline, (2) immediately after the intervention, (3) four-week after the interventions began, and (4) one-week after discontinuing the interventions. In control group, the maximum isometric trunk rotation force will be measured at three time points: (1) first session, (2) four-week after the study began, and (3) five-week after the study began. Method of measurement: This outcome will be measured using digital force gauge (Model: SF-500, Akurasi, 0.001kg) subject will be positioned on the chair in the upright sitting position. The subjects will be asked to rotate her trunk toward the opposite side and exert isometric force to force gauge probe. This test will perform again for other site. Joint position reproduction (JPR) of hip abduction. Timepoint: The Joint position reproduction (JPR) of hip abduction will be measured at four time points in intervention groups: (1) baseline, (2) immediately after the intervention, (3) four-week after the interventions began, and (4) one-week after discontinuing the interventions. In control group, this outcome will be measured at three time points: (1) first session, (2) four-week after the study began, and (3) five-week after the study began. Method of measurement: The Joint position reproduction (JPR) of hip abduction will be measured using the active JPR while standing. Three reflective markers will be attached to the apex of the iliac crest, greater trochanter, and lateral femur epicondyle. The movement of the reflective markers will be recorded using a Canon camera (EOS-500D, DS126231) placed behind the participant at a distance of 2.5 m.The camera’s tracking angles will be analyzed by Kinovea software (0.9.2, GPLv2 license, 2019). Disability score. Timepoint: Disability score will be measured at three time points in intervention groups: (1) first session, (2) four-week after the interventions began, (3) one-week after discontinuing the interventions. In control group, this outcome will be also measured at three time points: (1) first session, (2) four-week after the study began, and (3) five-week after the study began. Method of measurement: The Persian version of ODI will be used to quantify disability in women with post-partum pelvic pain. The tool is a 10-item questionnaire which mainly questioning about pain intensity related to the daily activities. Esfahan University of Medical Sciences Approved 2022-09-12 Ethical committee of Isfahan University of Medical Sciences Postal code: 81746-73461, Hezar Jerib St., Isfahan Isfahan Isfehan Iran (Islamic Republic of)